BACKGROUND: Shortness of breath, or dyspnea, is one of the most common symptoms experienced by patients with advanced cancer. It is particularly prevalent among breast and lung cancer patients. Curative treatment, such as tapping an effusion, is indicated for some patients but it is not always successful. There are only limited data from controlled trials on the value of pharmacologic approaches. Many patients do not respond to treatment and experience significant shortness of breath with consequent seriously impaired quality of life. Several randomized trials suggest that acupuncture may benefit conditions such as asthma and chronic obstructive pulmonary disorder. An uncontrolled study in advanced cancer reported immediate and clinically significant reductions in dyspnea following treatment. OBJECTIVES: We plan to conduct a randomized, blinded, placebo-controlled Phase III study of acupuncture for shortness of breath in advanced cancer. Such a study would aim to determine the immediate effect of acupuncture and the short-term effects of patient-self-administered acupressure. In this proposal, we plan to pilot such a study in order to refine accrual, treatment, placebo and data management procedures, and to determine whether a controlled trial is feasible and warranted. METHODS: Forty patients with breast or lung cancer will be accrued. Treatment consists of a single acupuncture session followed by administration of semi-permanent acupuncture needles ("studs"). Patients will be instructed on applying acupressure to the studs. Assignment to true treatment or placebo will be randomized, stratified by grade of breathlessness and cancer diagnosis. Placebo treatment consists of the "Streitberger" placebo needle, a device in which the needle retracts into the handle rather than piercing the skin, and a specially designed dummy stud. These will be placed at non-acupuncture points. Subjective breathlessness will be recorded for one hour immediately preceding and following the first acupuncture treatment and then twice a day for seven days. We will conduct a Phase III study if at least 75 percent of patients provide evaluable data; if accrual is sufficiently rapid so that, after suitable sample size calculations, a controlled trial could be completed in less than four years; and if the 95 percent confidence interval for the difference between group means includes at least a 20 percent greater improvement than placebo for either acupuncture or acupressure.